Plain English Summary
Background and study aims
Integrin αⅤβ3 is a receptor that is found on various types of tumor cell but not on (or very low on) normal cells. Therefore, it is becoming a valuable target for the diagnosis of tumors and monitoring the effects of treatment. Arginine-glycine-aspartic acid (RGD) can specifically bind to the integrin αⅤβ3 receptor. A variety of radioactively labeled (radiolabeled) RGD-based peptides have been developed for detecting integrin avb3 by positron emission tomography (PET) or single photon emission computed tomography (SPECT) scans. Among all the RGD radiotracers studied, 18F-Galacto-RGD and 18F-AH111585 have been well investigated and the results demonstrated that both radiotracers could be used to detect various types of tumors. Recently, new 99mTc-labeled RGD dimeric peptides have showed much higher binding to integrin avb3 and increased tumor uptake. 99mTc-3PRGD2 has been tested in lung cancer patients, appeared to be useful for diagnosis, and no side effects have been observed to date. The aim of this study is to assess the effectiveness of 99mTc-3PRGD2 for evaluating the early response of lung cancer to treatment.
Who can participate?
Patients aged 30 to 70 with lung cancer who are undergoing chemotherapy and/or molecular targeted treatment for at least 3 cycles or 3 months without radiotherapy
What does the study involve?
The study involves three 99mTc-3PRGD2 SPECT/CT scans at the start of the study, after one cycle, and after three cycles of treatment, respectively. An early evaluation after one cycle of therapy is compared with a standard evaluation after three cycles, and the new method is compared with CT and 18F-FDG PET/CT scans for evaluation.
What are the possible benefits and risks of participating?
Participants receive free 99mTc-3PRGD2 SPECT/CT scans and detailed medical follow-up. Participants are exposed to radiation from the low-dose CT and radiotracers. Possible side effects to the tracer 99mTc-3PRGD2 may occur, although no side effects have been observed to date.
Where is the study run from?
Peking Union Medical College Hospital (China)
When is the study starting and how long is it expected to run for?
February 2012 to February 2013
Who is funding the study?
1. Capital Special Project (China)
2. National Natural Science Foundation (China)
3. Ministry of Science and Technology (China)
Who is the main contact?
Prof. Fang Li
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2012-01
Study information
Scientific title
A multicenter clinical study of 99mTc-3PRGD2 SPECT/CT in an early response evaluation of lung cancer to chemotherapy and molecular-targeted therapy
Acronym
Study hypothesis
A group of clinically diagnosed lung cancer patients by 99mTc-3PRGD2 SPECT/CT and 18F-FDG PET/CT before treatment, treatment of early and late after the end of treatment or imaging to monitor tumor, treatment effect. According to PERICST standard in the evaluation of therapeutic effect.
The aim of this study is to compare 99mTc-3PRGD2 SPECT / CT with 18F-FDG PET/CT for response evaluation of lung cancer. The latter generally used PET Response Criteria in Solid Tumors (PERCIST) for response evaluation
Ethics approval
Peking Union Medical College Hospital, 16/11/2010, ref: S336
Study design
Prospective study design
Primary study design
Observational
Secondary study design
Cohort study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Lung cancer
Intervention
Single treatment arm will be used. Methodology: 99mTc-3PRGD2 SPECT/CT scans.
This is a diagnostic, single group assignment, open label efficacy study. Three 99mTc-3PRGD2 SPECT/CT scans will be performed at baseline, post one cycle, and post 3 cycles of treatment, respectively for each patient. 99mTc-3PRGD2 will be intravenously injected 40 minutes before each scan. The dose is 0.3 mCi/kg body weight (± 5%). Follow-ups will be performed every 3 months until the end of the study.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Changes of 99mTc-3PRGD2 uptake after one cycle of therapy compared to that after three cycles
2. Determine if the early uptake changes of 99mTc-3PRGD2 after one cycle of therapy compared to the baseline can reflect that of three cycles later
Secondary outcome measures
1. Changes of 99mTc-3PRGD2 uptake compared to those of CT and/or PET/CT
2. Determine if the 99mTc-3PRGD2 evaluations either post one cycle or post three cycles of treatment is better than or comparable to those of CT according to the RECIST criteria and/or PET/CT evaluations using PERCIST criteria
Overall trial start date
01/02/2012
Overall trial end date
01/02/2013
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age of 30 - 70 years
2. Clinical pathology in patients with lung cancer
3. Patients without radiotherapy
4. Radiation therapy
5. The clinical plan complete regimen in the treatment of patients
6. Can follow up the survival period of patients
7. Can obtain complete evaluation of the efficacy of imaging data before and after treatment
8. Volunteered to participate in and signed informed consent
Clinical diagnosis of pulmonary primary tumor, and without chemotherapy, radiotherapy patients, histologic type is not restricted. Clinical chemotherapy scheme is not restricted. Requirements of each patient in chemotherapy before a week, the first course of chemotherapy after the second chemotherapy was started 1 weeks prior to, and during the first chemotherapy 3 months after the start of the three time points respectively imaging ( including CT, MR and / or US control imaging ). If the patients during the treatment period replacement therapy must be recorded in detail. Requirements for follow-up each survival in patients with stage.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
More than 200 cases
Participant exclusion criteria
1. Withdrawal of informed consent
2. Loss to follow-up
3. Against research programme
Recruitment start date
01/02/2012
Recruitment end date
01/02/2013
Locations
Countries of recruitment
China
Trial participating centre
Peking Union Medical College Hospital
Beijing
100730
China
Sponsor information
Organisation
National Natural Science Foundation (China)
Sponsor details
83 Shuangqing Road
Haidian Area
Beijing
100085
China
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Capital Special Project (China) ref: Z111107058811096
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
National Natural Science Foundation of China
Alternative name(s)
National Science Foundation of China, Natural Science Foundation of China, NSFC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
China
Funder name
Ministry of Science and Technology of the People's Republic of China (ref: 2009ZX09103-733)
Alternative name(s)
Chinese Ministry of Science and Technology, MOST
Funding Body Type
government organisation
Funding Body Subtype
federal
Location
China
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list